Hepatocellular Carcinoma (HCC)
Conditions
Brief summary
This is a diagnostic study. This clinical trial aims to evaluate the diagnostic performance and safety of the novel radiotracer 18F-X12 in patients with hepatocellular carcinoma (HCC), and to provide evidence supporting a new approach for its early diagnosis, accurate staging and recurrence assessment.
Interventions
DIAGNOSTIC_TEST18F-X12 PET/CT
Participants will receive a single intravenous injection of 18F-X12, and undergo PET/CT imaging approximately 120 minutes after radiotracer administration.
Sponsors
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients aged ≥ 18 years old. * Patients fully understand the trial requirements, participate in the study voluntarily, and provide written informed consent. * Meet either of the following two conditions: * Patients with highly suspected hepatocellular carcinoma (HCC) (hepatic space-occupying lesion of undetermined nature on imaging examination) or pathologically confirmed HCC, with no prior systemic therapy (including immunotherapy, chemoradiotherapy, targeted therapy, etc.) or suspected tumor recurrence after previous treatment, and able to independently cooperate with relevant examinations. * Patients with clinically diagnosed HCC who have received 18F-FDG positron emission tomography/computed tomography (PET/CT) for clinical staging or post-treatment restaging, and able to independently cooperate with relevant examinations.
Exclusion criteria
* Patients with severe non-malignant diseases that may interfere with study objectives, or impair subject safety and study compliance, including but not limited to psychiatric disorders, infectious diseases, autoimmune diseases, and metabolic diseases. * Pregnant or lactating females. * Subjects who are unable to understand the examination procedure or cannot cooperate with trial-related examinations and operations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the diagnostic efficacy of 18F-X12 PET/CT for hepatocellular carcinoma (HCC). | From study completion to 1 month after completion | We calculated the diagnostic sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-X12 positron emission tomography (PET) imaging for patients with hepatocellular carcinoma (HCC), with histopathological results as the diagnostic gold-standard reference. |
| Incidence of Adverse Events [Safety and Tolerability] | 24 hours after the injection of 18F-X12 | Clinical symptoms and adverse events (e.g., fever, rash, hypoglycemia) will be monitored within 24 hours after injection, and graded according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 6.0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Values of Primary and Metastatic Lesions on ¹⁸F-X12 PET/CT versus ¹⁸F-FDG PET/CT | From the date of study completion up to 1-month post-completion | Comparison of the maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) of primary and metastatic lesions between 18F-X12 positron emission tomography/computed tomography (PET/CT) and 18F-fluorodeoxyglucose (FDG) PET/CT. |
| Correlation between 18F-X12 Uptake and GPC3 Pathological Expression | From the date of study completion up to 1-month post-completion | We evaluated the correlation between uptake parameters derived from 18F-X12 positron emission tomography/computed tomography (PET/CT) and Glypican-3 (GPC3) expression levels measured by immunohistochemistry (IHC) in tumor tissue samples. |
Countries
China
Contacts
CONTACTMeixi Chen
PRINCIPAL_INVESTIGATORMeng Liu
Peking University First Hospital
Outcome results
None listed